PBS Changes for Duodart® Bring GPs to the Fore on BPH Treatment

• PBS changes allow initiation of Duodart® by GPs following DUSC review
• GPs set to play more prominent role in BPH

Following recommendations by the Drug Utilisation Sub-Committee (DUSC) in regard to the treatment of Benign Prostatic Hyperplasia (BPH), the Pharmaceutical Benefits Scheme (PBS) criteria have now changed to allow General Practitioners (GPs) to initiate prescriptions for GSK’s Duodart®.

The changes came into effect from 1st June 2016.

Duodart1 scripts previously needed to be initiated by a urologist.

Duodart is a combination of two drugs with complementary mechanisms of action to improve symptoms in patients with moderate to severe Benign Prostatic Hyperplasia (BPH): dutasteride, a dual 5α-reductase inhibitor (5 ARI) and tamsulosin hydrochloride, an antagonist of α1a-adrenoreceptors1.

Duodart is PBS listed for Treatment of Lower Urinary Tract Symptoms (LUTS) in patients with moderate to severe BPH2.

The move has been welcomed by Professor Simon Willcock who is the Director of Primary Care Services at Macquarie University Hospital in Sydney. Professor Willcock has a special interest in the role played by GPs in men’s health.

“We need to make sure that GPs are assessing symptoms effectively and are referring patients where appropriate, but overall I think the move is set to improve access to effective BPH treatment for men. Anything we can do to smooth the path to effective treatment for BPH in men who have this condition really is a positive move,” said Professor Willcock.

According to Sydney-based urologist Associate Professor Manish Patel, specialists will still play a key role in the treatment of BPH.

“Clearly there will still be cases where the GP considers referral to a specialist as the appropriate treatment path. But in cases where the diagnosis is clear, GPs will be able to initiate treatment. I think overall this is a positive development,” said Associate Professor Patel.

Around one in three Australian men aged over 50 suffer from an enlarged prostate3. The condition can cause the need for frequent urination during the day, weak stream of urine and having to visit the bathroom more than once during the night4.

Prescribing information is available at au.gsk.com

Important safety information for Duodart® in Australia.

Duodart is indicated for the management of moderate to severe symptomatic benign prostatic hyperplasia (BPH)1.

There have been no clinical trials conducted with DUODART; however, co-administration information for Years 1 and 2 is available from the CombAT (Combination of Avodart and Tamsulosin) study. The tamsulosin component in Duodart is not bioequivalent to the tamsulosin product in Australia; however the clinical efficacy has been shown to be similar. Small differences in some adverse events have been reported (see PI for details).

The CombAT study found the occurrence of the following adverse events in ≥1% of patients: impotence, altered (decreased) libido, ejaculation disorders, breast disorders (includes breast tenderness and enlargement). Dizziness and syncope have also been reported1.

Healthcare professionals are advised to refer to the Full Product Information for further information regarding the safety of the product, including contraindications and precautions.

References:
1. Duodart Approved Product Information v11 http://au.gsk.com/media/290878/duodart_pi_011_approved.pdf
2. PBS criteria for Duodart. http://www.pbs.gov.au
3. Homma. (2007). Epidemiologic Survey of Lower Urinary Tract Symptoms in Asia and Australia Using the International Prostate Symptom Score. International Journal of Urology, 4, 40-46. http://onlinelibrary.wiley.com/doi/10.1111/j.1442-2042.1997.tb00138.x/pdf
4. Roehrborn, C. G. (2011). Male lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH). Medical Clinics of North America, 95(1), 87-100. http://www.sciencedirect.com/science/article/pii/S0025712510001483